The EU Medical Device Regulation, which comes into force on 26 May 2020, will lead not only to big changes in how medical devices are regulated, but also to more thought being given to agreements between a legal manufacturer (ie the entity placing a product on the market under its own name or trade mark) and third-party.
In particular, legal manufacturers will need to ensure that their suppliers are both complying with MDR and providing the necessary information and documentation back to the legal manufacturer so that the legal manufacturer can in turn comply with its owns obligations under MDR. Imposing a contractual obligation on a supplier to simply “comply with applicable law” is unlikely to be sufficient, both from a risk management perspective but also from a compliance perspective. Indeed, it is anticipated that competent authorities will be far stricter in ensuring that the regulatory obligations which MDR imposes on legal manufacturers are properly documented in relevant third party agreements.
This documentation process will be particularly important when a legal manufacturer outsources the manufacturing of a device to a third party. Most of the obligations placed on manufacturers under MDR are set out in Article 10 and many of them will need to be flowed down to a contract manufacturer. These include (amongst other things) an obligation to:
- establish, document, implement and maintain a risk management system in compliance with MDR;
- establish and maintain a technical folder of documentation to allow the legal manufacturer to create its own master technical folder for the device being manufacture;
- providing such assistance and documentation needed to allow the device to be granted a declaration of conformity;
- keep all technical documentation required by MDR for the prescribed periods of time;
- provide any such information to allow the legal manufacturer to meet its obligations regarding the UDI system;
- establish, keep up to date and continually improve a quality management system (“QMS”) at the manufacturing site (or placing an obligation on the contract manufacturer to comply with the legal manufacturer’s QMS system, requiring the contract manufacturer to comply with updates notified to it by the legal manufacturer);
- implement and keep up to date the post-market surveillance system and ensuring that any serious issues are notified to the legal manufacturer within specified timeframes;
- provide assistance in relation to product recalls and implementing correction action plans;
- implement a system for recording and reporting of incidents and field safety corrective actions;
- maintaining sufficient insurance coverage to deal with liabilities which may arise;
- cooperating with competent authorities and notified bodies, and allowing both them and the legal manufacturer to inspect the manufacturing site of the device; and
- employing a person or persons responsible for regulatory compliance having the qualifications stipulated by MDR.
Legal manufacturers should review the terms under which they contract with contract manufacturers to ensure that the allow the legal manufacturer to comply their obligations under MDR and that they will survive scrutiny from the relevant competent authorities.
As a side note from a UK perspective, it is currently anticipated that many provisions of the MDR (including those above) will continue to apply in the UK following the end of the Brexit transition period.
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